The Effect of Acupuncture on Symptoms, Gastric Emptying Rate and Glucose Control in Patients With Diabetic Gastroparesis

Sponsor

Rabin Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00874133

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

Diabetes affects 5.8% of the adult population in Israel (1). Gastroparesis is a syndrome characterized by delayed gastric emptying in the absence of mechanical obstruction of the stomach.Treatment with acupuncture has been described as effective in improvement of symptoms in patients with gastroparesis in a number of patient series. However, this treatment approach has not been tested by means of a controlled randomized clinical study, and neither has the connection between improvement of symptoms and the anatomical-physiological effect of the treatment, if ever, assessed.This study will test the efficacy of motilium (20 mg thrice daily) as compared to acupuncture treatment on the following subjective and objective parameters of 30 patients with diabetic gastroparesis and impaired glucose control:

To compare the degree of GCSI scores improvement before and after treatment with motilium or acupuncture using a validated questionnaire.
To determine the effect of treatment with motilium or acupuncture on gastric emptying rate.
To determine the effect of treatment with motilium or acupuncture on glycemic control.
To compare the quality of life before and after treatment with motilium or acupuncture using the Short Form-36 (SF-36).

Condition or Disease	Intervention/Treatment	Phase
Diabetic Gastroparesis	Procedure: Acupuncture Drug: Motilium	N/A

Detailed Description

This is a randomized, comparative, pilot study, which will compare two treatments:

acupuncture treatment vs. treatment with motilium in 30 diabetic patients with impaired glucose control and gastroparesis.

All patients who meet inclusion criteria will undergo gastric scintigraphy and upper endoscopy to assess the presence of gastroparesis and to rule out gastric outlet obstruction. At baseline, all enrolled patients will fill out the Gastroparesis Cardinal Symptom Index (GCSI), the Quality of life questionnaire (SF-36). Subsequently, patients will be randomized to 20 mg motilium thrice daily and after 1 month wash-out period to acupuncture treatment, each treatment will last 12 weeks.

After treatment, patients will undergo a second gastric scintigraphy and will complete the GCSI and the SF-36.

Fasting blood glucose concentrations and HbA1c levels will be determined at the beginning and at the end of the study and at 6 months later as well.

End Points:

Primary: Level of improvement of gastric emptying rate, and improvement in blood glucose levels at the end of treatment, in comparison with tests before treatment.

Secondary: Level of improvement in scores of severity of gastroparesis related symptoms, with quality of life indicators, in comparison with tests before treatment; also, the number of visits to family doctors/diabetic clinics/emergency rooms, as well as use of the medications resulting from diabetic complications will be investigated.

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effect of Acupuncture on Symptoms, Gastric Emptying Rate and Glucose Control in Patients With Diabetic Gastroparesis

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Motillium 20 mg motilium thrice daily for 12 weeks.	Drug: Motilium 20 mg motilium thrice daily Other Names: Domperidone
Active Comparator: Acupuncture Acupuncture treatment.	Procedure: Acupuncture Acupuncture treatment for 12 weeks. Other Names: Domperidone

Arm

Intervention/Treatment

Active Comparator: Motillium

20 mg motilium thrice daily for 12 weeks.

Drug: Motilium

20 mg motilium thrice daily

Other Names:

Domperidone

Active Comparator: Acupuncture

Acupuncture treatment.

Procedure: Acupuncture

Acupuncture treatment for 12 weeks.

Other Names:

Domperidone

Outcome Measures

Primary Outcome Measures

Level of improvement of gastric emptying rate [6 months]

Secondary Outcome Measures

Improvement in blood glucose levels [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age: 18-80,
Diabetic patients of over 10 years duration with impaired glucose control, after at least 6 months of accepted treatment in a Diabetes Clinic by the study staff before inclusion in the study, who exhibit symptoms which could signify the possibility of diabetic gastroparesis.

Exclusion Criteria:

Known hyperprolactinemia, systemic or localized neurological disturbances (myopathy, multiple sclerosis, Parkinson's disease, myelopathy), with the exception of diabetic neuropathy, past stomach or esophagus surgery, pregnancy, inability to sign Informed Consent, fear of acupuncture, limb amputation.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Rabin Medical Center

Investigators

Principal Investigator: Ram Dickman, MD, RMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

dickman ram, MD, Rabin Medical Center

ClinicalTrials.gov Identifier:

NCT00874133

Other Study ID Numbers:

004589

First Posted:

Apr 2, 2009

Last Update Posted:

Dec 6, 2013

Last Verified:

Dec 1, 2013

Additional relevant MeSH terms:

Gastroparesis

Domperidone

Study Results

No Results Posted as of Dec 6, 2013